Study Status
Show Details
Description
Value
Participants Enrolled
48
Sites Enrolled
158
Study Status
Active
Nickname
Protocol Nickname
Description
Value
Participants Enrolled
48
Sites Enrolled
158
Study Status
Active
Protocol Row Id
1-1G9113
Protocol Number
AA-AA-000-0000
Protocol Title
Protocol Title
Nickname
Protocol Nickname
Protocol Type
Investigator Sponsored
Phase
P3
Num Plan Site
190
Num Site Actl
176
Est Fpfv
2003-01-01
Act Fpfv
2003-01-01
Est Lplv
2021-06-01
Act Lplv
2021-06-01
Est Lpfv
2020-06-01
Act Lpfv
2020-06-01
Status
Active
Num Plan Subj
1300
Num Enrolled Subj M
1301
Protocol Indication
Protocol Indication
Product
Product
Therapeutic Area
Therapeutic Area
Protocol Product Number
123
X Rbm Flg
Y
Study Overview
As of 2012-12-31, AA-AA-000-0000 has 48 participants enrolled across 158
countries. 0 Site-KRI combinations have been flagged across 0 countries
as shown in the Study Overview Table above.
0 countries have at least one red KRI
3 countries have at least one red or amber KRI
3 countries have neither red nor amber KRIS and are not shown
Results
Adverse Event Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
US
43
9724
197416
0.05
-1.05
Serious Adverse Event Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
Non-Important Protocol Deviation Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
Important Protocol Deviation Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
Grade 3+ Lab Abnormality Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
Study Discontinuation Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
Treatment Discontinuation Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
Query Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
Outstanding Query Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
Outstanding Data Entry Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
Data Change Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
Screen Failure Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
Metric Details
File
MetricID
GroupLevel
Abbreviation
Metric
Numerator
Denominator
Model
Type
Score
Threshold
nMinDenominator
cou0001.yaml
cou0001
Country
AE
Adverse Event Rate
Adverse Events
Days on Study
Normal Approximation
rate
Adjusted Z-Score
-2,-1,2,3
30
cou0002.yaml
cou0002
Country
SAE
Serious Adverse Event Rate
Serious Adverse Events
Days on Study
Normal Approximation
rate
Adjusted Z-Score
-2,-1,2,3
30
cou0003.yaml
cou0003
Country
PD
Non-Important Protocol Deviation Rate
Non-Important Protocol Deviations
Days on Study
Normal Approximation
rate
Adjusted Z-Score
-3,-2,2,3
30
cou0004.yaml
cou0004
Country
PD
Important Protocol Deviation Rate
Important Protocol Deviations
Days on Study
Normal Approximation
rate
Adjusted Z-Score
-3,-2,2,3
30
cou0005.yaml
cou0005
Country
LB
Grade 3+ Lab Abnormality Rate
Grade 3+ Abnormal Labs Samples
Total Lab Samples
Normal Approximation
binary
Adjusted Z-Score
-3,-2,2,3
30
cou0006.yaml
cou0006
Country
SDSC
Study Discontinuation Rate
Subjects Discontinued - Study
Enrolled Subjects
Normal Approximation
binary
Adjusted Z-Score
-3,-2,2,3
3
cou0007.yaml
cou0007
Country
TDSC
Treatment Discontinuation Rate
Subjects Discontinued - Treatment
Enrolled Subjects
Normal Approximation
binary
Adjusted Z-Score
-3,-2,2,3
3
cou0008.yaml
cou0008
Country
QRY
Query Rate
Queries
Total Data Points
Normal Approximation
rate
Adjusted Z-Score
-3,-2,2,3
30
cou0009.yaml
cou0009
Country
OQRY
Outstanding Query Rate
Queries Open > 30 Days
Total Queries
Normal Approximation
binary
Adjusted Z-Score
-3,-2,2,3
30
cou0010.yaml
cou0010
Country
ODAT
Outstanding Data Entry Rate
Data Pages Entered > 10 Days
Total Data Pages
Normal Approximation
binary
Adjusted Z-Score
-3,-2,2,3
30
cou0011.yaml
cou0011
Country
CDAT
Data Change Rate
Data Points with 1+ Change
Total Data Points
Normal Approximation
binary
Adjusted Z-Score
-3,-2,2,3
30
cou0012.yaml
cou0012
Country
SF
Screen Failure Rate
Screen Failures
Screened Subjects
Normal Approximation
binary
Adjusted Z-Score
-3,-2,2,3
3